Clinical research - Today Stories

On June 25, 2019, AbbVie Inc. and Allergan announced that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie's common stock of $78.45 on June 24, 2019. Strategic Rationale: New growth platforms and leadership positions to diversify and expand revenue base: The combined company will consist of several attractive franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women's health, eye care and virology.  Allergan's product portfolio will be enhanced by AbbVie's commercial strength, expertise and international infrastructure. Immediate scale and en…

Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have announced that a Phase 2 proof-of-concept trial evaluating the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. The trial also met a key secondary endpoint, demonstrating REGN3500 monotherapy significantly improved lung function compared to placebo.  In the trial, the greatest improvement was observed in patients with blood eosinophil levels ≥300 cells/microliter. Patients treated with Dupixent® (dupilumab)  monotherapy did numerically better than REGN3500 across all endpoints, although the trial was not powered to show differences between active treatment arms. The combination of REGN3500 and Dupixent also did n…

A prestigious competition that has helped innovators raise millions of pounds to take their concepts to the global marketplace is looking for 2019’s most life-changing creations. The Royal Society of Chemistry’s Emerging Technologies Competition has helped winners raise more than £32million in funding since it was launched in 2013. Backed by some of the world’s biggest companies, such as Unilever, Croda, Johnson Matthey, RSSL and Pfizer, entries are now open until 5 July for the next big success story whose mastery of the chemical sciences helped create a product that can deliver a real-world benefit for wider society. Aurora Antemir, a senior manager in the Royal Society of Chemistry’s Industry team said: “In less than a decade, the Emerging Technologies Competition has gone from being an…

Neuraxpharm Group, a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces it will soon launch its first probiotic[1] in the European market following an exclusive licensing agreement with the probiotics company Bened Biomedical Co., Ltd. Bened Biomedical, an award winning 2015 spin-out from Taiwan-based National Yang-Ming University, develops functional probiotic strains that can alter human microbiome. The agreement secures Neuraxpharm exclusive rights to market its first probiotic, PS128™, in the European market. This is Neuraxpharm’s first launch of a probiotic product expanding the Company’s portfolio of marketed Consumer Healthcare products. This is in line with its ambition of covering CNS therapeutics from pr…

Greater Manchester is hosting an interactive event to kick-start a new campaign to get patients, carers and the public involved in clinical research. Be Part of Research is the new nationwide initiative from the National Institute for Health Research (NIHR), supported by NHS trusts across the country. A local launch is being hosted by the NIHR Clinical Research Network in Greater Manchester at Citylabs, Nelson Street, Manchester, on Friday 24 May, 10.30am to 2.30pm. Everyone is welcome to attend. But anyone who can’t make it can still get involved – by making a simple pledge to show their support for health and care research.* The event is an opportunity for patients, carers and the public to speak to healthcare professionals about research and see how they can get involved to help improve…

The development of the UK’s first dedicated Vaccines Manufacturing Innovation Centre (VMIC) has moved a step closer with the contract to design an advanced array of laboratory and production facilities within a ‘cleanroom wrap’ environment being awarded to WHP. The multi-disciplinary engineering company has won the design work as part of plans for the specification of versatile new cGMP suites and filling rooms for the VMIC, which is being built in the Oxford area. These units will have the capacity to meet Department of Health and Social Care requirements concerning the provision of vaccines in an infectious disease emergency. The centre, which has secured £66m of funding from UK Research and Innovation, is being developed through the UK Government’s Industrial Strategy Challenge Fund (IS…

Elucid mHealth has developed a smart pill dispensing solution called Pill Connect which will allow both trial investigators and doctors to effectively monitor medication adherence, either in clinical trials or in the community. Elucid is already in discussions with several top tier Pharmas, CROs, CMOs, and the NHS all of whom all keen to find effective ways to monitor patient adherence. The first clinical trial undertaken by a global CRO with healthy people has just been concluded. The trial showed that the system worked very well. How the system works Preparation - A patient has an app loaded onto their mobile phone (iPhone or android) which contains the pill regime – eg twice a day. Is trained how to use the app – 20 minutes - and given a Pill Connect bottle loaded with pills Patient us…

Frimley, UK, May 8, 2019 – Novartis today announced a new subgroup analysis of the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in patients with secondary progressive multiple sclerosis (SPMS). The results show siponimod, the first and only oral drug to delay disability progression in SPMS patients, has significant functional benefit on cognitive processing speed (CPS), the cognitive function most frequently affected by MSi,ii,[iv]. The new findings, presented at the 2019 American Academy of Neurology Annual Meeting (AAN) in Philadelphia, Pennsylvania, USA, show that patients treated earlier in their disease course with less cognitive impairment benefited most from siponimod treatment vs. placeboi. This suggests that earlier treatment can lead to better cognitive outcomes,…

Cambridge, 29th April 2019: The Xaar 1201 printhead is proving instrumental in helping Nottingham-based research organisation, Added Scientific, establish the suitability of inkjet printing in the manufacture of personalised pharmaceutical pills, where dosages could be tailored to individuals on an industrial scale. Building on research conducted by the University of Nottingham, where excipients (everything but the active pharmaceutical ingredient [API]) have been developed, Added Scientific initiated a project with its collaborators Xaar and AstraZeneca to look at the long-term scalability and suitability of inkjet printing in dispensing APIs. The project was funded under the Industrial Strategy Challenge Fund’s Medicines Manufacturing Challenge, with support from Innovate UK. “Inkjet pri…

London, UK – 23 April 2019: Ergomed plc, (LSE: ERGO) ('Ergomed' or the 'Company'), a company focused on providing specialised services to the pharmaceutical industry, today announces that PrimeVigilance, its pharmacovigilance, regulatory and medical information service provider, has been awarded the Queen’s Award for Enterprise for the second time reinforcing Ergomed’s broad leadership position as a provider of contract services. Now in its 53rd year, the Queen’s Awards for Enterprise are the most prestigious business awards in the country. Ergomed’s PrimeVigilance has received the 2019 Queen’s Award for International Trade in recognition of its year-on-year outstanding services in the drug safety sector for its global customer base. As an International Trade winner, PrimeVigilance has dem…

Berkshire based PharmiWeb are excited to have launched a new version of of PharmiWeb.com - The new site, focusing on News, Events and Articles from the Pharma sector, brings together a wide range of content from multiple sources, to make the site an even better resource for the Pharma Industry.  Pharma Jobs  The hugely popular Job Board has moved to a new URL - PharmiWeb.Jobs. This means that for individuals looking for a the latest jobs in the pharma industry, PharmiWeb's new job board will the only place they need to go!  According to Portal Business Manager, Mike Wood - "This is the start of a very exciting growth stage for PharmiWeb, and we have a wide ranging plan of developments for the portal which will reinforce our position as one of the primary sources of global Pharma news. Our…

CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary Polyzene™-F nanocoating technology, today announced that it has signed a three-year group purchasing agreement with HealthTrust for its novel COBRA PzF™ NanoCoated Coronary Stent (NCS) System. The agreement (contract number: 39949), which became effective on February 1, 2019, provides HealthTrust's more than 1,500 member hospitals and health systems with access to the world's first non drug-eluting, nanocoated coronary stent designed to help physicians safely and effectively treat patients who may benefit from short, 1-month minimum dual antiplatelet therapy (DAPT).1 DAPT has been shown to increase bleeding and mortality risks, which is of greater c…

*         ICARIA (Isatuximab in Combination with pomalidomide And low-dose dexamethasone veRsus pomalidomide and low dose dexamethasone in patients with refractory or relapsed And refractory Multiple Myeloma), study evaluated the benefit of isatuximab in combination with standard of care in prolonging progression free survival as compared to standard of care in patients with relapsed/refractory multiple myeloma *         Multiple myeloma is the second most common haematological cancer1 *         First randomised Phase 3 trial to evaluate the benefit of adding a monoclonal antibody to pomalidomide and dexamethasone for treatment of relapsed/refractory multiple myeloma I…

Merck, a leading science and technology company, and GSK, a science-led global healthcare company, today announced that the companies have entered into a global strategic alliance to jointly develop and commercialize M7824 (bintrafusp alfa*). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers. This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).   M7824 is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β (TGF-β) trap and an anti-programmed cell death ligand-1 (PD-L1…

Torque, an immuno-oncology company developing first-in-class Deep Primed™ T Cell Therapeutics to direct immune power deep within the tumor microenvironment, and Thermo Fisher Scientific Inc. (NYSE: TMO), today announced a collaboration to build a dedicated Slipstream™ manufacturing facility for high-efficiency production of Torque's Deep-Primed T cell immunotherapies. Buildout of the Torque/Thermo Fisher manufacturing facility has begun, and the companies anticipate processing patient cells by the end of 2019. The Slipstream platform will initially be used in the clinical development of Torque's lead Deep-Primed T cell candidate, TRQ-1501, in solid and hematologic tumors; followed by TRQ-1201, also for solid and hematologic tumors. "Torque's cell manufacturing technology platform is crit…

Neuraxpharm Group, a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders (CNS), announces the acquisition of Farmax, a CNS specialty pharmaceutical company, from SVUS Pharma.   Farmax, located in Hradec Králové, Czech Republic, was the commercial division of SVUS Pharma, and has a strong distribution presence in the Czech Republic, Slovakia as well as a small presence in Hungary. Farmax is a leader in sales and marketing both branded and non-branded generics pharmaceuticals for CNS disorders such as Zolpinox®. It also commercializes well-known OTC nutraceuticals such as Preventan® and Maxicor®. Farmax has been renamed Neuraxpharm Bohemia and will commercialize its products under the Neuraxpharm brand. Leveraging its proprie…

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced a worldwide collaboration and license agreement with MeiraGTx Holdings plc (NASDAQ: MGTX), a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia (ACHM) caused by mutations in either CNGB3 or CNGA3, and X-linked retinitis pigmentosa (XLRP). Further, the companies have formed a research collaboration to explore new targets for other inherited retinal diseases and further develop adeno-associated virus (AAV) manufacturing technology. "Janssen is excited to expand our portfolio with the addition of innovative assets that have the potential to improve sight or prevent the progressi…

Beckman Coulter Life Sciences today announced its acquisition of Labcyte, a privately held, acoustic liquid handling company based in San Jose, California. Labcyte is best known for its Echo® acoustic droplet ejection technology, which uses sound waves to transfer tiny amounts of liquid with unequalled speed and accuracy. This technology—the centerpiece of Labcyte's Echo Liquid Handlers—enables walkaway convenience and integration capabilities. Labcyte technology enables faster and more cost-effective laboratory workflows in applications such as drug discovery and genomics. "Labcyte's unique product portfolio complements our existing liquid handling and laboratory automation business. It provides new opportunities to develop and enhance time-saving solutions for customer workflows," said J…

UPMC Health Plan and AstraZeneca today announced the initiation of a pioneering value-based contract effective Jan.1, 2019 for UPMC for Life Medicare members who are prescribed BRILINTA® (ticagrelor), a medication used to lower a patient's chances of having another heart attack or dying from one in the 12 months following a heart attack. The goal of the contract is to align the incentives of the manufacturer, AstraZeneca, with UPMC Health Plan by connecting reimbursement for BRILINTA® to clinical outcomes in a real-world population. Specifically, reimbursement for the medication will be linked to cardiovascular outcomes for people treated with BRILINTA® following a recent hospitalization for heart attack or unstable angina. This value-based contract is groundbreaking in two way…

Purdue Pharma L.P. (“Purdue”) and Alivio Therapeutics today announced that they have entered into a partnership to advance one of Alivio’s product candidates through clinical development with an option exercisable by Purdue to collaborate on a limited number of additional compounds utilising Alivio’s inflammation-targeting technology. ALV-107 is a non-opioid treatment being developed for interstitial cystitis/bladder pain syndrome (IC/BPS).   Alivio will receive up to $14.75 million in upfront and near-term license exercise payments and is eligible to receive royalties on product sales and over $260 million in research and development milestones. Purdue also has an option to invest in Alivio’s next equity financing.   “This collaboration with Alivio is an important milestone…